End-expiratory Occlusion Test and Prediction of Preload Dependence

End-expiratory Occlusion Test and Prediction of Preload Dependence: Echocardiographic and Hemodynamic Study in the ICU.

Three sets of measurements of hemodynamic parameters and sub-aortic VTI were performed: before and at the end of 15 seconds end-expiratory occlusion and after 250 mL saline administration over 10 minutes. Patients were considered responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion. SPSS was used for statistic study. A p < 0.05 was considered significant. The investigators performed univariate and then multivariate analysis.

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Intensive Care Units; Blood Volume
• Intervention / Treatment: Diagnostic test: End-expiratory occlusion test

Detailed Description

The patients included were in the supine position in a prone position at 30°. They had continuous monitoring by: electrocardioscopy; pulse oximetry and invasive blood pressure. Diuresis was monitored hourly.

A venous access to the superior vena cava territory (central venous catheter) was set up.

The patients were sedated with a Ramsay score > 4 and ventilated in controlled assisted mode.

The sub-aortic TVI (in cm) was measured in an apical 5-chamber section by pulsed Doppler using a 1-5 MHz ultrasound probe (M-Turbo sonosite). Three sets of measurements of hemodynamic parameters and sub-aortic VTI were performed: before and at the end of 15 seconds end-expiratory occlusion and after 250 mL saline administration over 10 minutes. At each point, the investigators noted the hemodynamic, ultrasound and biological parameters.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 2085
    • Mongi slim hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Sixty patients were included. The main causes of admission in intensive care were traumatic causes, post operative care or medical causes. 35 were responders avec 25 non responders to fluid load.

Description

Inclusion Criteria:

• Patients under mechanical ventilation and sedation in the intensive care units
• patients for whom the decision of 250 mL saline administration was taken for : hypotension (systolic pression under 90 mmHg or diatolic pression under 40 mmHg or tachycardia more than 90 pulse per minute or oliguria or the increase in cathecholamin needs.

Exclusion Criteria:

• Pulmonary Edema
• arrythmia
• dialysis
• Prone position

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Responders to fluid challenge; Responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion.	Diagnostic test: End-expiratory occlusion test; 15 seconds end-expiratory occlusion
Non responders to fluid challenge; Non responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion.	Diagnostic test: End-expiratory occlusion test; 15 seconds end-expiratory occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
an increase in sub-aortic VTI of more than 10%	the variation of sub aortic VTI by cardiac ultrasonography	before and 10 minutes after 250 mL saline administration

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital
• Investigators: Principal Investigator: Mhamed Sami MS Mebazaa, Pr, Mongi slim hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TOTE Rea

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No